[Photo provided by GC Pharma]
GC Pharma gained more test grounds for its investigational blood plasma-derived therapy for Covid-19 patients.
The Ministry of Food and Drug Safety endorsed requests from Asan Medical Center and SoonChunHyang University Bucheon Hospital to use the therapy to treat symptoms of the virus infection, according to industry sources on Tuesday.
GC Pharma’s hyperimmune globulin treatment manufactured with active immune antibodies from the plasma of convalescent patients is under Phase 2 trial in high-risk patients.
The treatment-purpose approval system allows the MFDS to grant approval on using an unapproved investigational drug for urgent patients either with life-threatening condition or without alternative treatment.
The first treatment-purpose approval for GC Pharma’s plasma therapy was granted for the treatment of patients at Kyungpook National University Chilgok Hospital on Oct. 19. Additional approvals were issued for patients at SoonChunHyang University Bucheon Hospital on Oct. 28 and Ajou university Hospital on Oct. 30.
GC Pharma is now conducting Phase 2 clinical trials of the therapy at 12 hospitals with a target subject number of 60. As of Tuesday, 11 patients completed enrollment.
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